CARS

Coumadin Aspirin Reinfarction Study (1997)

Condition

Reduction of cardiovascular events following acute myocardial infarction 

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Objective

To investigate, whether a combination of low-dose warfarin and low-dose ASA would give superior results to standard ASA monotherapy without excessive bleeding risk

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Trial design

Randomized, double-blind controlled study
Active treatment:

  • warfarin 3 mg plus ASA 80 mg once daily (n=3382)
  • warfarin 1 mg plus ASA 80 mg once daily (n=2028)

Control treatment: ASA 160 mg once daily (n=3393)

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Endpoints

Primary efficacy endpoints: non-fatal myocardial reinfarction, non-fatal ischemic stroke and cardiovascular death
Secondary efficacy endpoints: all-cause mortality, silent myocardial infarction, unstable angina requiring admission to hospital, TIA and systemic (non-CNS) embolization
Primary safety endpoint: major hemorrhagic events 

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Trial participants

8803 patients between 21 and 85 years, enrolled 3–21 days after a recent myocardial infarction

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Results

Primary outcome: A primary event occurred in 295 of 3382 patients (8.4% 1-year life-table estimate) in the 3 mg warfarin group, 237 of 2028 patients (estimate 8.8%) in the 1 mg warfarin group and in 308 of 3393 patients (estimate 8.6%) in the ASA monotherapy group
Safety outcome: For major (not procedure related) hemorrhage, 1-year life-table estimates were 1.4% for the 3 mg warfarin group (n=52), 1.0% in the 1 mg warfarin group (n=26) and 0.7% in the ASS monotherapy group (n=30) 

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Summary

Efficacy: In patients with recent myocardial infarction, low, fixed-dose warfarin (1 mg or 3 mg) combined with low-dose ASA (80 mg) does not provide a greater risk reduction of myocardial reinfarction, stroke and cardiovascular death than 160 mg ASA monotherapy 
Safety: Spontaneous major hemorrhage (not procedure-related) occurred more frequently in the 3 mg warfarin/ASA group compared to ASA alone. There was no significant difference between 1 mg warfarin/ASA and ASA alone, and also among all groups concerning any major hemorrhage

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Reference

Fuster V, Califf RM, Chesebro JH, Cohen M, Comp PC, Gheorghiade M, Hall J, Halperin J, Khan S, Kopecky S, Langer A, Molk B, Moss A, O’Connor CM, O’Gara PT, Raskob E, Sutton J. Randomised double-blind trial of fixed low-dose warfarin with aspirin after myocardial infarction. Lancet 1997;350:389-396

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Corresponding author

Valentin Fuster, MD, Mount Sinai Hospital, Box 1030, 1 Gustave Levy Place, New York, NY 10029, USA

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